Module 14: Design Development and Certification of Medical Devices

17/11/2023

Effect of MDR

• More products are covered by the Regulation • Some products are reclassified • Fewer products fall into Class I, self-certified, and those upclassified devices will need NB assessment • Greater expectations for supporting performance/effectiveness • Importance of well written clinical evaluation report and design history • All products being be reassessed for conformance with MDR requirements (no grandfathering)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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Documentation

What do we need for our CE/UKCA mark? • STED (Summary Technical Documentation) file

STED is the basis on which the Declaration of Conformity, and hence compliance with the Essential Principles, is DEMONSTRATED Where do we get the information from to complete the STED? • Manufacturer’s Technical Documentation • Documents generated under the manufacturer’s Quality Management System • Safety and performance studies • IMDRF gives a nice overview of how documents in the Manufacturer’s Technical Documentation translate into a STED file

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

6

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